FDA 510(k) Application Details - K243039

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K243039
Device Name	Stent, Ureteral
Applicant	Alton (Shanghai) Medical Instruments Co. Ltd No.24 Building Jinshao Rd 1688.Baoshan District. Shanghai 200949 CN Other 510(k) Applications for this Company
Contact	Vivian Li Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	06/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review